NCT04989699CompletedPhase 1
Study Evaluating the Treatment of OTX-TKI for Subjects With Neovascular Age-related Macular Degeneration
A Prospective Multicenter, Double-Masked, Randomized, Parallel-Group, Study to Evaluate the Safety, Tolerability, and Efficacy of OTX-TKI (Axitinib Implant) for Intravitreal Use in Subjects With Neovascular Age-Related Macular Degeneration (nAMD)
Source: ClinicalTrials.gov · Last updated 26 Jan 2024
Brief summary (registry, in English)
Evaluate the safety, tolerability, and efficacy of OTX-TKI for intravitreal use in subjects with Neovascular Age-Related Macular Degeneration
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 21 (actual)
- First submitted
- 2 Jul 2021
- Start date
- 28 Jul 2021
- Primary completion date
- 6 Feb 2023
- Lead sponsor
- Ocular Therapeutix, Inc.
- Diseases
- Macular degeneration
- NCT number
- NCT04989699
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 21
- From 28 Jul 2021 to the primary completion date, 6 Feb 2023
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Have presence of a disease other than choroidal neovascular membrane (CNVM) due to AMD in the study eye that could affect vision or safety assessments
Other
- Have evidence of a scar, fibrosis or atrophy of \>50% of the total lesion in the study eye
- Have monocular vision (fellow eye Snellen BCVA is 20/200 or worse
Who the study is looking for
- Have a diagnosis, within 3 years of screening, of previously treated subfoveal neovascularization (SFNV) secondary to nAMD with leakage involving the fovea, previously treated with documented evidence of an initially favorable clinical response to anti-VEGF therapy (i.e. aflibercept, ranibizumab, brolucizumab, or bevacizumab).
- The macular appearance on OCT is considered to be free of excess intraretinal and/or subretinal fluid as judged by the investigator.
- Must have received at least 3 anti-VEGF injections in the past year.
- Have received the most recent anti-VEGF injection within the past 1-4 weeks prior to screening visit.
- BCVA ETDRS score between 24 and 83 letters (\~20/25 to \~20/320 Snellen equivalent)
Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ocular Therapeutix Coordinator of this site? Confirm its status | Altamonte Springs | United States | Unknown status |
| Ocular Therapeutix Coordinator of this site? Confirm its status | Bakersfield | United States | Unknown status |
| Ocular Therapeutix Coordinator of this site? Confirm its status | Oxnard | United States | Unknown status |
| Ocular Therapeutix Coordinator of this site? Confirm its status | Reno | United States | Unknown status |
| Ocular Therapeutix Coordinator of this site? Confirm its status | St. Petersburg | United States | Unknown status |
| Ocular Therapeutix Coordinator of this site? Confirm its status | The Woodlands | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.